A patch used by applying onto the skin has a layer structure including a support, and a pressure-sensitive adhesive layer provided on at least one surface of the support. Further, in order to protect the front surface of the pressure-sensitive adhesive layer, a release layer is arranged, or for example, when the support is extremely thin and the like, a layer structure in which a carrier layer of a carrier film or the like is provided on the support may often be provided.
A patch is applied on the skin and then removed, thereafter in many cases, a new patch is applied, and thus the patch that does not fall off from the skin for an intended period of time, can be removed easily and beautifully, and further does not strongly stimulate the skin is required. In addition, when the patch is applied on an exposed area of the skin in daily life, it may be demanded that the applied site is unnoticeable.
In other words, it is required that a patch have an appropriate adhesive force. When the adhesive force is too weak, the patch may be easily removed from the surface of the skin, or the patch may not be applied along a skin surface with fine irregularities such as sulcus cutis. When the adhesive force is too strong, the patch may cause skin irritation, or the peeling off after use may become difficult.
A facial surface is an area where sebum is secreted largely as compared with an arm, a shoulder, and the like. When a patch is applied on a facial surface where sebum is secreted largely, particularly when a patch is applied on an eyelid, a pressure-sensitive adhesive of a pressure-sensitive adhesive layer absorbs the sebum that has been secreted from the skin of eyelid, and thus the cohesive force of the pressure-sensitive adhesive is decreased, and there may be a possibility that the patch is easily removed. Therefore, in order that the patch is not removed from the skin even when absorbing a large amount of sebum, it has been considered that the thickness of the pressure-sensitive adhesive layer is needed to be sufficiently thick.
In the facial surface, eyelid is a facial surface area that not only particularly draws the attention of other people but also has extremely large number of times of expansion and contraction by movements, such as a blinking that is repeated at all times. Therefore, for a patch applied on an eyelid, the eyelid is an area where not only the tackiness but also the less skin stimulation is strongly required.
By the way, chalazion, blepharitis, meibomian gland dysfunction, allergic conjunctivitis, vernal conjunctivitis, atopic conjunctivitis, and the like are known as diseases that are caused by inflammation of eyelid and palpebral conjunctiva. For example, chalazion is a mass of a meibomian gland that located on the back of eyelid in eyelid tissue, and as a method of the treatment, in addition to incision and scraping, a steroid therapy can be performed.
As a steroid therapy, an intralesional steroid injection has been performed. However, in the steroid injection, there is a pain at the time of injection, a formation of white subcutaneous (steroid) deposit at the injection site, and a complication after the steroid injection such as decoloration and atrophoderma, and in extremely rare cases, retina and choroid vascular occlusions may be caused after the steroid injection. Therefore, a removal treatment by surgical operation may be performed for the complete cure, however, imposes a heavy burden on the patient.
Therefore, in order to resolve these problems, a patch containing steroid for treatment of eyelid disease is desired. From Patent Literature 1 (WO 2004/064817), a patch in which a remedy for eyelid diseases such as adrenal cortical hormone is mixed has been known. A patch for treatment of eyelid diseases is less transferred into the eyes (tear fluid) as compared with other ophthalmic drop formulations such as eye-drops, and has the advantage that a risk of ocular hypertension or cataract induced by steroid can be reduced. Further, in the patch, pain by an injection or surgical operation is not accompanied, the sustainability of the drug is kept, and a short-term treatment is expected.
An eyelid patch to be used for treatment of eyelid diseases by a steroid therapy usually contains steroid in a pressure-sensitive adhesive layer. In Patent Literature 2 (Japanese Patent Application Laid-Open No. S63-230635), a transdermal patch containing corticosteroid such as clobetasol in a pressure-sensitive adhesive layer, that is, a patch for treatment has been disclosed, however, a patch for treatment of eyelid diseases has not specifically suggested. Hereinafter, clobetasol or the acid ester thereof may be collectively simply referred to as “clobetasol”. Therefore, a patch for treatment of eyelid diseases, which is provided with a pressure-sensitive adhesive layer containing clobetasol, is capable of applying on the skin of eyelid over a long period of time, and has less residual adhesive and is gentle to the skin, has been required. In addition, a patch for treatment of eyelid diseases which is unnoticeable in an applied state, has also been required.
In the above-mentioned Patent Literature 1, a patch in which a drug for eyelid diseases such as adrenal corticosteroid is mixed, that is, a transdermal drug delivery system for treatment of ophthalmic diseases has been described, and as a pressure-sensitive adhesive layer, a pressure-sensitive adhesive layer composed of a rubber-based pressure-sensitive adhesive, an acrylic pressure-sensitive adhesive, or a silicone-based pressure-sensitive adhesive has been disclosed.
Further, in Patent Literature 3 (Japanese Patent Application Laid-Open No. H05-17346), a patch for medical use, in which a pressure-sensitive adhesive layer including an adhesive basis that contains paraffinic hydrocarbon and/or naphthenic hydrocarbon and an alicyclic hydrocarbon resin, and a styrene-isoprene-styrene block copolymer, is provided on one surface of a support, has been disclosed, and as the support, a synthetic resin film such as polyester, polyethylene, polyvinyl chloride, polyvinylidene chloride, polyethylene-vinyl acetate copolymers, and polyurethane; nonwoven fabrics; cloth; aluminum foil; and the like have been mentioned, and also use of a soft vinyl chloride film with a thickness of 135 μm has been specifically disclosed. Furthermore, in Patent Literature 4 (WO 2006/092829), a patch for external use laminated with a pressure-sensitive adhesive layer in which a styrene-isoprene-styrene block copolymer, a tackifier resin, and a softening agent are mixed as essential components, and flurbiprofen is mixed as an active component, on a support, has been disclosed, and as the support, nonwoven fabrics and fabrics have been mentioned.
However, a conventional patch has not yet had sufficient effects as a patch for treatment of eyelid diseases, the improvement of the patch for treatment of eyelid diseases provided with a pressure-sensitive adhesive layer that contains clobetasol has been required. In addition, it is desirable that the amount of a drug such as steroid is kept to the minimum, and the high percutaneous permeability is realized. Therefore, a combination of a support and a pressure-sensitive adhesive layer appropriate for a patch for treatment of eyelid disease, which is provided with a pressure-sensitive adhesive layer that contains a small amount of clobetasol, is capable of applying on the skin of eyelid over a long hours, and has less residual adhesive and is gentle to the skin, has been required.